Antiseptic applicator with mechanism for fracturing multiple ampoules

ABSTRACT

Hand-held applicators for applying antiseptic are provided. More specifically, the present invention relates to a hand-held applicator having at least one flexible elongated hollow body within which at least two antiseptic-filled ampoules are received, and a mechanism for fracturing the ampoules to release the antiseptic for dispensing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation and claims priority to U.S. patentapplication Ser. No. 10/748,896, filed on Dec. 30, 2003, which hasmatured into U.S. Pat. No. 6,991,394, filed on Dec. 30, 2003, and claimspriority to U.S. Provisional Application No. 60/439,197, filed on Jan.10, 2003.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable.

BACKGROUND

Applicators for applying liquids such as medicaments or cleansing agentsare known in the prior art. Conventional applicators typically provide agenerally cylindrical body construction and include only one glassampoule retained within the body; a sponge or tip secured to the body,at least one surface of which is exposed to the ampoule; and a means forfracturing the ampoule such that when the ampoule is fractured, theliquid stored therein is dispensed to the sponge for application.

Some prior art discloses more than one ampoule retained within the bodyof the applicator. In such applicators, the liquid-filled ampoules aretypically fractured by the user grasping the body wall and exerting asqueezing force directly thereon. Of course, the squeezing forcenecessary to fracture two ampoules depends upon a number of factors suchas the shape of the ampoule, the material of which the body and ampoulesare formed, and the location at which the force is exerted.

Numerous problems are encountered with applicators of this type. Forexample, it is difficult to fracture more than one ampoule in thismanner and may require a user employ both hands to break the ampoulesdispensing the fluid. Furthermore, because so much effort is required tofracture more than one ampoule, it may be difficult for the user tofracture more than one ampoule at the same time.

Other prior art has revealed applicators with more than one ampoule anda mechanism for breaking the ampoules one at a time. Again, thisrequires that the user employ both hands to fracture more than oneampoule. Furthermore, breaking ampoules one at a time is inefficient andis not reliable.

In many situations, it is necessary for the user of a liquid dispenserof antiseptics or medicaments to use one hand to expose or position aportion of a patient's body which is to be treated with the liquid,while preparing the dispenser for use and applying the liquid with theother hand. For example, liquid applicators are often used to apply apre-operative liquid, such as an isopropyl alcohol or iodine basedsolution, to an area of the body just prior to surgery. Thus, it isessential that the user be able to prepare and use the applicator withonly one hand in order to enable the practical use thereof.

SUMMARY

Accordingly, in one of its aspects, the present invention provides animproved hand-held liquid applicator of quality construction having abody with a mechanism that may be depressed to fracture more than oneampoule enclosed therein substantially simultaneously, releasing theliquid contained in the ampoules so that the liquid may be applied bythe porous element attached to the body of the applicator.

Additional aspects of the invention, together with the advantages andnovel features appurtenant thereto, will be set forth in part in thedescription which follows, and in part will become apparent to thoseskilled in the art upon examination of the following, or may be learnedfrom the practice of the invention. The objects and advantages of theinvention may be realized and attained by means, instrumentalities andcombinations particularly pointed out in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying drawings which form a part of the specification andare to be read in conjunction therewith, and in which like referencenumerals are employed to indicate like parts in the various views:

FIG. 1 is a perspective view of a liquid applicator constructed inaccordance with an embodiment of the invention;

FIG. 2 is a side plan view constructed in accordance with an embodimentof the invention;

FIG. 3 is a top plan view of a liquid applicator constructed inaccordance with an embodiment of the invention with a portion of theapplicator body removed to expose the inside of the body and theampoules;

FIG. 4 is a side plan view of a liquid applicator constructed inaccordance with an embodiment of the invention with a portion of theapplicator body removed to expose the inside of the body and theampoules;

FIG. 5 is a side plan view of a liquid applicator constructed inaccordance with an embodiment of the invention with a portion of theapplicator body removed to expose the two ampoules being fractured atsubstantially the same time by the lever;

FIG. 6 is a side plan view of a the cap of a liquid applicatorconstructed in accordance with an embodiment of the invention;

FIG. 7 is a fragmentary cross-sectional view taken generally across line7—7 of FIG. 5;

FIG. 8 is an exploded view of the vent located at the distal end of theapplicator enclosed by line 8 in FIG. 3;

FIG. 9 is a side plan view of a liquid applicator constructed inaccordance with an embodiment of the invention with a portion of theapplicator body removed to expose the ampoules being fractured by thelever;

FIG. 10 is a fragmentary cross-sectional view taken generally acrossline 10—10 of FIG. 2; and

FIG. 11 is a fragmentary cross-sectional view taken generally acrossline 11—11 of FIG. 4.

DETAILED DESCRIPTION

A liquid applicator for applying a desired liquid to a surface, theapplicator comprises a hollow body defining an internal chamber toreceive at least two elongated ampoules formed of a frangible materialand containing the liquid to be applied is described. The liquidapplicator further comprises a lever projecting from the body, the leverflexing said body inwardly to fracture the ampoules substantiallysimultaneously when the lever is depressed toward the body. The liquidapplicator further comprises a porous element secured to the body of theapplicator and closing off an open end, such that liquid flows throughthe porous element to be applied to a surface. The following areexamples of embodiments of the present invention and are illustrativerather than restrictive.

EXAMPLE 1

With reference FIG. 1, FIG. 2 and FIG. 3 in particular, where likereference numerals identify like elements in the various views, anembodiment of the liquid applicator is illustrated and designatedgenerally by the numeral 10. Liquid applicator 10 generally includes abody 12, and a porous element 16 secured to flange 24 of body 12 and alever 26.

Two ampoules 14 and 15 are received in body 12. Ampoules 14 and 15 maybe used for containing various liquids such as medicaments, cleansingagents, cosmetics, polishes or the like. In the illustrated embodiment,ampoules 14 and 15 contain antiseptic solution to be applied to apatient's skin prior to surgery. Ampoules 14 and 15 are illustrated aselongated cylinders each with a central longitudinal axis. However, itwill be appreciated that the principles of the present invention alsomay be applied to spherical or elongated polygonal ampoules.Furthermore, it will be appreciated that the principles of the presentinvention may be applied to more than two ampoules.

Preferably, ampoules 14 and 15 are formed of glass, although othermaterials are entirely within the scope of the present invention. In theillustrated embodiment, ampoules 14 and 15 are placed side by sidewithin body 12. The wall of glass ampoules 14 and 15 is of a thicknesssufficient to contain the desired liquid during transport and storage,yet allow ampoules 14 and 15 to be fractured upon the application oflocalized pressure.

Referring now to FIGS. 4, 5, 6 and 7 body 12 is generally hollow andoval or elliptical in shape and includes axially opposed first andsecond ends 18, 20. The proximal first end 18 is open and distal secondend 20 is closed with cap 19 shown in FIG. 6. Illustrated body 12 isformed of high-density polyethylene, although any material exhibitingsimilar flexibility and integrity may be used. In the illustratedembodiment, body 12 and cap 19 were molded with 100% virgin materialDOW, HDPE, Resin # 12454N, as defined in FDA Master File Number 4251. Inthe preferred embodiment, second end 20 is closed with cap 19, howeversecond end may also be closed during the molding process obviating theneed for a cap or the like.

Referring again to FIGS. 1, 2, 3 and 4, body 12 includes an interiorwall 21 which defines an internal chamber 22 within body 12. Interiorwall 21 is shaped to conform generally to the shape of ampoules 14 and15 which are received within internal chamber 22. The circumference ofinterior wall 21 is slightly larger than the outer surface of the twoampoule bodies. Dividing wall 17 of hollow body 12 separates ampoules 14and 15 and maintains ampoules 14 and 15 within internal chamber 22.Illustrated body 12 is elongated and defines a central longitudinal axis“x”.

The thickness of the wall of the applicator may be between 0.040 to0.080 inches and preferably is approximately 0.060 inches, except thinwall 40. The thickness of the wall of body 12 is reduced around crusharea 42. Thin wall 40 may be between 0.020 to 0.040 inches andpreferably is 0.030 inches. However, it will be appreciated thatdifferent wall sizes may be used within the scope of the embodiment ofthe invention. Thin wall 40 makes it easier for crush portion 36 oflever 26 to fracture multiple ampoules when lever 26 is depressed. Thiswill be discussed in more detail later.

Body 12 further presents a flange 24 protruding from proximal end 18along the periphery thereof. In the preferred embodiment, flange 24 iscontinuously molded to body 12 and is disposed at an angle. Preferably,flange 24 is disposed an angle of 45°, with respect to the centrallongitudinal axis of the body. It will be appreciated that flange 24 maybe disposed at a variety of angles with respect to the centrallongitudinal axis of body 12. Flange 24 is adapted to support porouselement 16, as more fully described below.

Porous element 16, such as a sponge or the like, closes off open end 18of body 12. Porous element 16 is received on flange 24 and enclosesampoules 14 and 15 within internal chamber 22. Porous element 16 may beformed of felt or an open-celled foam material. In the illustratedembodiment, porous element 16 was formed of SIF-#3-1000Z felt, (NaturalColor Non-Pigmented) Reticulated Polyester Urethane. This felt ishydrophobic and works well with alcohol-based liquids. In anotherembodiment, AQUAZONE™ polyurethane foam, manufactured by E.N. Murray Co.in Denver, Colo., is used. The AQUAZONE™ foam is hydrophilic and workswell with water based liquids.

Porous element 16 is cut from a sheet of foam or felt material havingthe desired porosity for the liquid to be dispensed. Porous element 16is preferably generally square in shape although it will be appreciatedthat the element may be of any desired size and shape which is capableof being supported on flange 24.

In the illustrated embodiment, a woven or non-woven laminate material islaminated to porous element 16. The material laminate material may be awoven or non-woven polyester material. In the illustrated embodiment,Novonnete® SP-64 (3905) Polyester (Non-Woven) was laminated to0.360″±0.032″ SIF-#3-1000Z felt, (Natural Color Non-Pigmented)Reticulated Polyester Urethane. The laminate material is positionedbetween porous element 16 and flange 24 of body 12. As such, thelaminate material functions to prevent shards of glass from thefractured ampoules from pushing through the porous element during use ofthe applicator. The laminate material also provides a suitable weldingmaterial for securing the porous element in place on the body when anultrasonic welding operation is used to manufacture the applicator.

In the illustrated embodiment, porous plug 46 is positioned betweenporous element 16 and ampoules 14 and 15. Porous plug 46 may be anopen-celled foam material or felt. In the illustrated embodiment,Novonette® SP-64 (3905) Polyester (Non-Woven) was laminated to0.360″±0.032″ SIF-#3-1000Z Felt, (Natural Color Non-Pigmented)Reticulated Polyester Urethane. Porous plug 46 helps control the rateliquid flows from the body and prevents shards of glass from pushingthrough porous element 16 during use of the applicator. Porous plug 46is cut from a sheet of foam or felt material having the desired porosityfor the liquid to be dispensed.

Body 12 also includes a lever 26 projecting from the top portion of body12. However, it will be appreciated that lever 26 may project from anyportion of body 12. Lever 26 is any mechanism for fracturing more thanone ampoule at substantially the same time. Lever 26, includes hingeportion 38, crush portion 36 and handling portion 34 extending from thedistal end of lever 26. Preferably, lever 26 extends outwardly from body12 at an angle of between 20° and 40° with respect to the centrallongitudinal axis of body 12. More preferably, lever 26 extends frombody 12 at approximately 27° with respect to the central longitudinalaxis “x” of body 12. It will be appreciated that lever 26 may bedisposed at a variety of angles with respect to the central longitudinalaxis of body 12.

In the illustrated embodiment, lever 26 is continuously molded with body12. It will be understood and appreciated, however, that separatelyformed levers are contemplated to be within the scope of the presentinvention.

Handling portion 34 of lever 26 of the illustrated embodiment is spacedbetween 0.5 and 1.5 inches from body 12. Preferably, handling portion 34is spaced approximately 1.0 inch from body 12. Handling portion 34 oflever 26 includes a textured outer surface to facilitate handling ofapplicator 10 and to inhibit slippage from the user's hand duringapplication.

In the illustrated embodiment, lever 26 includes crush portion 36 andhinge portion 38 attached to body 12. It will be appreciated, however,that the principles of the present invention are equally applicable tovarious other structures for fracturing ampoules 14 and 15, such asmultiple crush portions, multiple hinge portions and a crush portionthat may be attached or detached to body 12. The hinge portion 38anchors one end of the lever 26 against the body 12 of the applicator,thus when the lever 26 is depressed, force is transferred into the crushportion 36 of the lever 26. Handling portion 34 of lever 26 presents agripping area which is significantly larger than the area of crushportion 36. Upon depression of lever 26, crush portion 36, flexes body12 inwardly at thin wall 40, thereby localizing the forces effected bydepressing lever 26 toward body 12 and enhancing fracturing of ampoules14 and 15 as more fully described below.

Several features of lever 26 of the illustrated embodiment enhance theability to fracture at least two ampoules at the same time including:the thickness of lever 26, the curvature of lever 26, support rib 37 (asillustrated in FIG. 2), the thickness of hinge portion 38 and the widthof crush portion 36. The thickness of lever 26 is approximately 0.080 to0.15 inches and preferably is 0.11 inches. In the illustratedembodiment, lever 26 is approximately 2.35 inches long. Hinge portion 38of the illustrated embodiment is thinner than the rest of lever 26.Hinge portion 38 is approximately 0.040 to 0.080 inches thick,preferably 0.060 inches thick. The curvature of lever 26 and support rib37 increase the leverage of handling portion 34 of lever 26 making iteasier for the user to fracture two ampoules substantiallysimultaneously.

The ratio of the width of crush portion 36 to the width of ampoules 14and 15 side by side is important with respect to reliable breakage ofampoules 14 and 15. In the illustrated embodiment, the width of thecrush portion 36 had to be at least approximately ⅕ the width of the twoampoules side by side to produce breakage of the ampoules almostsimultaneously. The width of the two ampoules side by side wasapproximately 1.03 inches. The minimum width of the crush portion of thelever that produces breakage of the ampoules almost simultaneously was0.200 inches. Thus, a length aspect ratio for reliable ampoule break was1.03/0.200 or 5.15. All of these features, either singularly or incombination, along with thin wall 40, help enhance the ability of thelever to break multiple ampoules at the same time. In the preferredembodiment of the present invention, the crush portion of the lever was0.675 inches. The width of the two ampoules side by side isapproximately 1.03 inches. Thus, the preferred length aspect ratio is1.03/0.675 or 1.53.

With reference to FIG. 7 and FIG. 8, vent 56 of the illustratedembodiment is shown. Vent 56 is located at distal end 20 of body 12.Vent 56 is a small cut out portion of body 12 allowing air to flow frominternal chamber 22 of body 12 to the outside of body 12 and vice versa.This is accomplished by a small cut out portion of body 12 starting onthe outside of body 12, going over the lip of body 12 and continuinginside body 12. Internal cut out portion 54, external cut out portion 50and cut out lip 52 allow air to flow in and out of internal chamber 12of body 12 underneath cap 19. Cap 19 entirely seals off internal chamber22 except for cut out vent 56.

With reference to FIG. 9 and FIG. 11, restraint element 44 is positionedbetween ampoules 14 and 15 and porous plug 46. Restraint element 44allows liquid to flow from body 12, through porous plug 46 and intoporous element 16. Restraint element 44 restrains ampoules 14 and 15 ina position to facilitate proper breaking. Restraint element 44 holds theends of ampoules 14 and 15 near crush point 42 so that the ends ofampoules are properly broken and do not restrict the flow of liquid.Restraint element 44 may take a variety of shapes depending on the typeof liquid to be applied. In the illustrated embodiment, restraintelement 44 has two fan-shaped openings as may be seen in FIG. 11.

With reference to FIGS. 5, 9, 10 and 11, in use, applicator 10 presentsa hand held liquid applicator wherein lever 26 is depressed to releasethe desired liquid contained within ampoules 14 and 15 therein forapplication to a surface. Applicator 10 of the illustrated embodiment isgrasped by one hand of a user. The bottom of body 12 is grasped with thepalm and fingers of user; the user's fingers wrap around the bottom andside of the body 10 so the tips of the user's fingers rest on the top ofbody 12. The thumb of the same hand is positioned on handling portion 34of lever 26 allowing for single handed operation. The user depresseslever 26 toward body 12 to fracture ampoules 14 and 15. The movement oflever 26 is transferred by crush portion 36 to thin wail 40 of body 12to deform body 12 inwardly and exert discrete localized fracturingforces against ampoules 14 and 15. Lever 26 provides an action thatgains mechanical advantage as lever 26 is depressed toward body 12.Accordingly, if the user has limited gripping strength, or if the wallof the ampoule is exceptionally thick, the lever ensures fracturing ofthe ampoules.

Once lever 26 has been sufficiently depressed, the resulting forcesfracture ampoules 14 and 15 almost simultaneously, thus releasing theliquid contained in each ampoule. Once ampoules 14 and 15 are fractured,the released liquid saturates porous plug element 46 which controls therate of the flow and then the liquid saturates porous element 16.Consequently, body 12 essentially functions as a reservoir of thedesired liquid. When the applicator is manipulated for scrubbing withthe distal end oriented away from the surface to be scrubbed and theporous element oriented toward the surface as shown in FIG. 1, theliquid will flow from the fractured ampoule under the force of gravitydown body 12, through porous plug 46 the through open end 18 and throughporous element 16. Thereafter, application of the liquid is accomplishedby bringing porous element 16 into contact with the desired surface. Theuser may then use a painting or scrubbing motion to apply the liquid tothe surface. The entire process of fracturing ampoules 14 and 15 andapplying the liquid to a desired surface is achieved with the use ofonly one hand of the user.

EXAMPLE 2

In this embodiment, the liquid applicator 10 is constructed to house two13 ml ampoules. The thickness of the walls of the 13 ml ampoules is 0.3mm. It will be understood and appreciated, however, that ampoules ofvarious sizes with various wall widths may be utilized and such iscontemplated to be within the scope of the present invention. In theillustrated embodiment, the distance between the lateral line defined bythe most upwardly positioned portion of the flange and the distal end ofthe handling portion of the lever is approximately 3.75 inches. It willbe understood and appreciated, however, that this distance will varybased upon the size of the applicator and ampoule utilized. Suchvariations are contemplated to be within the scope of the presentinvention.

EXAMPLE 3

During formation of the applicator, the porous element is welded to theapplicator body in three steps. First, the flange of the body ispre-heated with the aid of an infrared heater that is set at atemperature ranging between 620 and 625° F. The flange and the body areheld in place with a nesting fixture, and a gap between the flange andthe heating element is set to 0.125″. The flange is heated forapproximately fifteen seconds to achieve a temperature of approximately150 to 160° F. Next, the porous plug is manually inserted into theapplicator body while the flange area is still warm. Finally, while thepre-heated body and flange containing the porous plug are still in thenesting fixture, a porous element is centered onto the flange. Theflange and the porous element are bonded together with a sonic weldingmachine. It will be appreciated that other suitable securing expedientscould be employed in place of the ultrasonic welding operation. Forexample, the porous element could be secured in place by an adhesive orstitching, or by heat sealing or chemically bonding the element inplace. Such alternative securing expedients are contemplated to bewithin the scope of the present invention.

The completed applicator body containing the porous plug with the porouselement secured to the flange is removed from the fixture. Two 13 mlampoules are inserted through the distal opening into the applicatorbody. The cap is inserted into position using a customized pneumaticpress and nesting fixture. Finally, the cap is compressed into its finalposition closing the applicator body at the distal end.

Constructed and operated as previously described, this inventionprovides a hand-held liquid applicator of quality construction having abody with a lever that may be depressed toward the body to fracture atleast two ampoules of liquid contained within the body. Further, thisinvention provides a disposable liquid applicator which permitssingle-handed operation in order to free the second hand of the user foruse in assisting application of the liquid to the desired area. Theliquid applicator of the present invention also is simple to constructand assemble and, therefore, may be manufactured more economically thanprior art applications.

From the foregoing, it will be seen that this invention is one welladapted to attain all the ends and objects hereinabove set forthtogether with other advantages which are obvious and which are inherentin the structure.

It will be understood that certain features and subcombinations are ofutility and may be employed without reference to other features andsubcombinations. This is contemplated by and is within the scope of theclaims.

Since many possible embodiments may be made of the invention withoutdeparting from the scope thereof, it is to be understood that all matterherein set forth or shown in the accompanying drawings is to beinterpreted as illustrative and not in a limiting sense.

1. An applicator for applying a desired antiseptic to a surface, theapplicator comprising: at least two elongated ampoules formed of afrangible material and containing antiseptic to be applied; an elongatedhollow body, said body defining at least one internal chamber adapted toreceive said ampoules; at least one lever projecting from said body,said lever flexing said body inwardly to fracture said ampoulessubstantially simultaneously when the lever is squeezed toward the body;and a porous element secured to said body and closing off an open endthereof, such that antiseptic flows through said element when saidampoules are fractured.
 2. The applicator of claim 1, wherein the leveris comprised of a hinge portion, crush portion and handling portion. 3.The applicator of claim 2, wherein the body has a central longitudinalaxis.
 4. The applicator of claim 3, wherein the lever extends at anangle of between 20 degrees and 40 degrees with respect to the centrallongitudinal axis of the body.
 5. The applicator of claim 2, wherein thecrush portion of the lever flexes the body inwardly to fracture saidampoules.
 6. The applicator of claim 2, further comprising a thin wallportion of the body where the body flexed inwardly to fracture saidampoules.
 7. The applicator of claim 2, wherein the lever is curved. 8.The applicator of claim 7, wherein the lever further comprises a supportrib.
 9. The applicator of claim 8, wherein the hinge portion of thelever is thinner than the rest of the lever.
 10. The applicator of claim9, wherein the handling portion of the lever presents a gripping areathat is larger than the area of the crush portion of the lever.
 11. Theapplicator of claim 10, wherein the handling portion has a texturedouter surface to facilitate handling.
 12. The applicator of claim 1,wherein the body has axially opposed open and closed ends.
 13. Theapplicator of claim 12, wherein the closed end is closed with a cap. 14.The applicator of claim 13, further comprising: a vent for allowing airto flow from the internal chamber of the body to the outside of thebody.
 15. The applicator of claim 14, wherein the vent comprises aninternal cut out portion of the body and an external cut out portion ofthe body.
 16. The applicator of claim 1, further comprising a porousplug positioned between the porous element and the two or more ampoulesto control the rate of flow of the antiseptic.
 17. The applicator ofclaim 16, further comprising a restraint element positioned between theampoules and the porous plug.
 18. An applicator for applying antisepticto a surface, the applicator comprising: at least two elongated ampoulesformed of a frangible material and containing the antiseptic to beapplied; at least one elongated hollow body, said at least one bodydefining at least one internal chamber adapted to receive said ampoules;at least one mechanism attached to said body, the at least one mechanismhaving the capability of flexing said at least one body inwardly tofracture said ampoules at substantially the same time; and at least oneporous element secured to said at least one body and closing off an openend thereof, such that antiseptic flows through said at least oneelement when said ampoules are fractured.
 19. The applicator of claim18, further comprising a porous plug positioned between the at least oneporous element and the two or more ampoules to control the rate of flowof the antiseptic.
 20. The applicator of claim 18, further comprising arestraint element.